Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

Tennessee Devicemaker Cited for Risk Analysis, Labeling

The FDA hit Nashville-based CNMC Company with a Form 483 over inadequate risk analysis and device labeling procedures observed by an agency investigator during a March inspection.

The firm’s procedures for controlling and inspecting device labeling did not document label release. The facility did not document any label inspections or releases for its EquiDose II Diode Detector dose monitors.

In addition, the agency said, the company performed incomplete risk analysis for its Model 206 Electrometer device, failing to address possible hazards related to functional failures.